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China Medical Device Registration

National Medical Products Administration (NMPA) approval timelines and requirements

2-4 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

China Agent

China Medical Device Registration Overview

China medical device registration through NMPA typically takes 2-4 months for Class I devices. The official NMPA target is 1 week, but realistic timelines include preparation, documentation review, and potential questions from regulators.China uses a 3-class (I, II, III) risk-based classification system. Foreign manufacturers must appoint a China Agent to register devices in China. Registration is valid for 5 years (Class II & III), Unlimited (Class I).

Registration Timeline by Device Class

China uses a 3-class (I, II, III) risk-based classification system.

Class I

Filing/Recordation

Low Risk

Official

1 week

Realistic

2-4 months

• No expiration

• Filed with municipal authority (domestic) or NMPA (imported)

Class II

Provincial Registration

Medium Risk

Official

4 months

Realistic

1-1.5 years

• In-country testing required (~6 months)

• Clinical often exempted

Local Testing RequiredGMP/QMS Required

Class III

NMPA Registration

Highest Risk

Official

5-6 months

Realistic

2-3 years

With Prior Approval

1.2-1.7 years

Accelerated with: Priority review for innovative devices, Hainan pilot

• Clinical trials often required

• In-country testing 6-9 months

Clinical Trial RequiredLocal Testing RequiredGMP/QMS Required

Expedited Pathways

Priority Review (Innovative Devices)

Expedited review for rare diseases, malignant tumors, pediatric devices

6-12 months faster

Eligibility: Significant clinical advantage, No alternative treatment, Innovative technology

Hainan Boao Pilot Zone

Fast-track initial use with real-world data collection

4 months vs 3-5 years standard

Eligibility: Approved overseas (FDA, CE), Not yet registered in China nationally

Greater Bay Area (GBA) Connect

Fast-track for Hong Kong/Macau approved devices

Access to 9 major cities

Eligibility: Hong Kong or Macau approval

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your China registration.

FDA 510(k)/PMA

Required as home country approval

Required documentation

EU CE Mark

Required as home country approval

Required documentation

Foreign Clinical Data

May be accepted if China GCP compliant

12-18 months if accepted

Key Requirements

China Agent (mandatory for foreign manufacturers)
In-country testing at NMPA-certified lab
Chinese labeling and IFU
Clinical trial (Class III, unless exempted)
GMP compliance (Class II & III)

Registration Validity:

5 years (Class II & III), Unlimited (Class I)

Registration Process Flowchart

China Medical Device Registration Process

Step-by-step NMPA registration process. Total estimated timeline: 2-4 months.

Step 1: Device Classification

2-4 weeks

Classify device under NMPA rules (Class I, II, or III). Class III requires full registration.

Step 2: In-Country Testing

3-6 months

Testing at NMPA-designated Chinese laboratories required for most Class II/III devices.

Step 3: Clinical Trial (if required)

12-24 months

Many Class II/III devices require Chinese clinical trials. Can take 12-24 months.

Step 4: Appoint Agent

2-4 weeks

Foreign manufacturers must appoint a Chinese agent/legal representative for submissions.

Step 5: NMPA Application

1-2 weeks

Submit registration dossier to NMPA/CFDA. Documentation must be in Chinese.

Step 6: NMPA Review

12-18 months

NMPA conducts technical review. Multiple Q&A rounds common. Average 12-18 months for Class III.

Step 7: Registration Certificate

2-4 weeks

NMPA issues registration certificate. Valid 5 years with annual renewal requirements.

Summary: The China medical device registration process through National Medical Products Administration (NMPA) consists of 7 main steps: Device Classification → In-Country Testing → Clinical Trial (if required) → Appoint Agent → NMPA Application → NMPA Review → Registration Certificate.

DJ Fang

MedTech Regulatory Expert

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Related Resources

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.